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What is Zelnorm®?
Zelnorm® (tegaserod maleate) is a prescription medication approved for short term treatment of women with irritable bowel syndrome (IBS) with constipation and for patients younger than 65 years with chronic constipation. Zelnorm® works by increasing the movement of stools through the bowels. Zelnorm® is manufactured and marketed by Novartis Pharmaceuticals Corporation.
What is Irritable Bowel Syndrome?
Irritable bowel syndrome (IBS) is a condition characterized by chronic abdominal pain associated with alterations in bowel habits. Sufferers of irritable bowel syndrome may have predominantly diarrhea or predominantly constipation, or may alternate between the two.
Why was Zelnorm® removed from the market?
On March 30, 2007, upon the FDA's request, Novartis agreed to stop selling Zelnorm®. Zelnorm® was taken off the market because of a new safety analysis that found a higher incidence of heart attack, stroke and worsening heart chest pain in patients treated with Zelnorm® compared to those treated with a sugar pill (or placebo). Although the number of patients who suffered an event of this nature was small, the patients treated with Zelnorm® had a higher chance of having any of these life-threatening side effects than did those who were given the placebo. All of the patients affected had pre-existing cardiovascular disease and/or cardiovascular risk factors.
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What should I do if I am taking Zelnorm®?
If you are currently being treated with Zelnorm® you should contact your physician to discuss alternative treatments for your condition. You should also seek emergency medical care right away if you experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness, difficulty walking or talking, or other symptoms of a heart attack or stroke. Novartis will refund you any out-of-pocket costs for any unused, unexpired tablets returned. You can contact Novartis at (888)-NOW-NOVA (888-669-6682) for more information.
What are other treatment options for irritable bowel syndrome?
There are a number of over-the-counter (OTC) and prescription laxative therapies that are still available. Unfortunately, Zelnorm® was somewhat unique in its ability to address a variety of symptoms in IBS and constipation patients. Laxatives like Milk of Magnesia, lactulose and polyethylene glycol (PEG) have all been shown to improve stool frequency and stool consistency in patients who have constipation but haven't been carefully evaluated for IBS. A new chloride channel activator called Amitiza® (lubiprostone) has also been shown to be of benefit in constipation.
For additional information talk to you physician or pharmacist, or visit www.fda.gov or www.zelnorm.com.
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